Amoxsan

AMOXSAN®
Capsule, Dry Syrup, Pediatric Drops, Dispersible Tablet

COMPOSITIONS

Capsule	:	Each capsule contains Amoxicillin Trihydrate equivalent to 250 mg/500 mg of Amoxicillin.
Dry Syrup	:	When dispersed with drinking water, each 5 ml contains Amoxicillin Trihydrate equivalent to 125 mg/250 mg of Amoxicillin.
Pediatric Drops	:	When dispersed with drinking water, each ml contains Amoxicillin Trihydrate equivalent to 100 mg of Amoxicillin.
Dispersible Tablet	:	Each tablet contains Amoxiclllin Trihydrate equivalent to 250 mg of Amoxicillin.

PHARMACOLOGY
Amoxicillin is a derivative of semisynthetic penicillin which is acid stable. Its bactericidal activity is similar to that of ampicillin.
Amoxicillin is rapidly and well absorbed from the gastrointestinal tract, irrespective of the presence of food, giving a high blood level after one hour. Its absorption is better than that of ampicillin, Amoxicillin is mainly excreted through the kidneys, in the urine Amoxicillin is recovered in active form.
Amoxicillin is effective against Gram-positive and Gram-negative organisms. Among those bacteria which are sensitive to Amoxicillin are:

Staphylococcus Streptococcus Diplococcus pneumoniae Bacillus anthracis Enterococcus Corynebacterium diphtheriae Salmonella sp

Shigella sp H. Influenzae Proteus mirabilis E. coli N. gonorrhoeae N. meningitidis

INDICATIONS

• Respiratory tract infections:
  
• Tonsillitis, sinusitis, laryngitis, pharyngitis, otitis media, bronchitis, bronchiectasis. pneumonia.
  
• Genitourinary tract Infections:
  
• Pyelonephritis, cystitis, urethritis, gonorrhoea.
  
• Skin and soft tissue Infections:
  
• Wounds, cellulitis, furunculosis, pyoderma.

CONTRA-INDICATIONS

• Hypersensitivity to beta-lactam antibiotics e.g. penicillins, cephalosporins.
  
• Babies born of mothers hypersensitive to penicillin.

ADVERSE REACTIONS

• Hypersensitivity reactions such as erythematous maculopapular rashes, urticaria, skin rashes, serum sickness.
  
• Serious and fatal hypersensitivity reaction is anaphylaxis, especially in patient with hypersensitivity condition to penicillin.
  
• Gastrointestinal disturbances, such as nausea, vomiting and diarrhoea.
  
• Haematological reactions (usually reversible).
  

PRECAUTIONS

• Before initiating therapy with Amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin.
  
• Amoxicillin must be used with caution in pregnant and lactating women.
  
• Periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy.
  
• Patient with renal disorder must be monitored for its plasma and urine level.
  
• As with other antibiotics, Amoxicillin administration may cause superinfection (the common causes are Pseudomonas, Enterobacterium, S. aureus and Candida). If it occurs, treatment should be discontinued and appropriate therapy should be instituted.
  
• Not for meningitis or body joint treatment (since oral Amoxicillin does not penetrate the cerebrospinal or sinovial liquid).
  
• Caution should be taken when this drug is administered to patients with lymphatic leukemia due to Amoxicillin-induced skin rash susceptibility.
  
• Amoxicillin administration may cause severe colitis.
  

DRUG INTERACTIONS

• Probenecid may increase and prolong blood level of Amoxicillin.
  
• Concomitant use with allopurinol may result in increased skin reactions.
  

DOSAGES

• Moderate Infections
  
• Adults and children ≥ 20 kg: 250 mg - 500 mg every 8 hours.
  
• Children with body weight of ‹ 20 kg: 20-40 mg/kg body weight/day in divided doses every 8 hours.
  
• For more severe infections higher doses may be given.
  
• For patients receiving peritoneal dialysis, recommended maximum dose is 500 mg/day.
  
• For treatment of Gonococcus urethritis: 3000 mg as a single dose.
  
• Dry syrup is recommended for children › 8 kg: 125mg-250 mg every 8 hours.
  
• Pediatric drops are recommended for children under 6 months of age.
  Usually dosage for ail indication except infections of the lower respiratory tract:
  
• ‹ 6 kg : 0.25 ml - 0.50 ml every 8 hours.
  
• 6 - 8 kg: 0.50 ml -1.0 ml every 8 hours.
  
Infections of the lower respiratory tract:

• ‹ 6 kg : 0.50 ml -1.0 ml every 8 hours.
  
• 6-8 kg: 1.0ml-1.5 ml every 8 hours.
  

Direction for suspension and dispersible tablet preparation

• Dry Syrup, for volume 60 ml.
  
• Pour drinking water until slightly below mark. Close bottle tightly. Hold bottle upside-down and shake until all granules are dispersed. Add sufficient drinking water up to mark (60 ml) and shake well.
  
• Pediatric Drops, for volume 15 ml.
  
• Pour 8 ml of drinking water. Close bottle tightly. Hold bottle upside-down and shake until all powder are dispersed.
  After reconstitution with drinking water, the suspension must be used within 7 days.
  Store in a refrigerator (2°- 8°C) or in a place away from light.
  
• Dispersible Tablet
  
• Dissolve one dispersible tablet into a spoonful of drinking water (teaspoonful or spoonful) wait for about 30-40 seconds until the tablet is completely dispersed into small granules. The suspension may be directly given to patient, followed by drinking water.
  

SPECIAL DOSAGE RECOMMENDATIONS FOR SPECIFIC INFECTIONS

Renal function impairment condition

For patients with renal impairment monitoring of drug concentration in plasma and urine should be undertaken. Suggested dosages: Moderate renal impairment with creatinine clearance 10-30 ml/min; 1 g followed by 500 mg every 12 hours. Severe renal Impairment with creatinine clearance 10 ml/min; 1 g followed by 500 mg every 24 hours.

SPECIFIC DOSAGE RECOMMENDATIONS

Typhoid and paratyphoid	Adults: 4g daily in divided doses for 14-21 days. Children: 100 mg/kg body weight/day in divided doses for 14 - 21 days
Typhoid carrier states	3 - 4 g daily in divided doses for a minimum of one month.
Gonorrhoea	A single dose of 3 g + 1 g probenecid where infection is caused by penicillin sensitive organisms.
Uncomplicated urinary tract infections	A single dose of 3 g.
Syphilis	250 mg every 6 hours has been used in all stages of syphilis. Duration of treatment varied from 4 weeks up to 5 months according to the stage of disease and serological response.
Severe or recurrent lower respiratory tract infection	3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Dental abscess	3 g twice daily with 8 hours between doses
Otitis media	In severe or recurrent otitis media, especially where compliance may be a problem, 750 mg twice daily for two days, may be used In children 3-10 years of age.

ON MEDICAL PRESCRIPTION ONLY

PRESENTATIONS

Capsule	:	Box of 10 strips 9 10 capsules.
Dry Syrup	:	Bottle containing dry syrup to be dispersed with drinking water up to 60 ml.
Pediatric Drops	:	Bottle containing dry syrup to be dispersed with drinking water up to 15 ml.
Dispersible Tablet	:	Box of 10 strips @ 10 tablets.

Reg. No.:

AMOXSAN® 250 Capsule	:
AMOXSAN® 500 Capsule	:
AMOXSAN® Dry Syrup	:	DKL0732401438A1
AMOXSAN® Forte Dry Syrup	:	DKL0732401438B1
AMOXSAN® Pediatric Drops	:	DKL0732401336A1
AMOXSAN® Dispersible Tablet	:	DKL0732401281A1

STORAGE
Store at room temperature (25°- 30°C), away from light.

Manufactured by:
PT SANBE FARMA
Bandung - Indonesia

For:
PT CAPRIFARMINDO LABS.
Bandung – Indonesia

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